Fuchuang Pharmaceutical Group 1.1 fcn-411, a subsidiary of Fuxing Pharmaceutical Holding Co., Ltd., obtained clinical approval

Announcement of Shanghai Fosun Pharmaceutical (Group) Co., Ltd on the approval of holding subsidiaries for drug clinical trials the board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the contents of this announcement, and bear individual and joint liabilities for the authenticity, accuracy and integrity of the contents I overview Recently, fcn-411 capsule (acceptance No.: cxhl1502036 Yu, cxhl1502038 Yu) and its API (acceptance No.: cxhl1502033 Yu) (hereinafter referred to as "the company") developed by Chongqing fuchuang Pharmaceutical Research Co., Ltd., a holding subsidiary of Shanghai Fuxing Pharmaceutical (Group) Co., Ltd (hereinafter referred to as "Chongqing fuchuang") and its API (acceptance No.: cxhl1502033 Yu) (hereinafter referred to as "the company") "The new drug") was approved by the State Food and Drug Administration (hereinafter referred to as "the State Food and Drug Administration") for clinical trials (approval No.: 2016l03331, 2016l03332, 2016l03333) 2 Basic information of the new drug 1 Drug name: fcn-411 capsule dosage form: capsule specification: 2mg application items: domestic drug registration classification: original chemical class 1.1 applicant: Chongqing re creation approval conclusion: agree to carry out clinical trial of the product 2 Drug name: fcn-411 capsule dosage form: capsule specification: 8mg application item: domestic drug registration classification: original chemical class 1.1 applicant: Chongqing re creation approval conclusion: agree to carry out clinical trial of this product 3 Drug name: fcn-411 capsule type: API Application items: Registration classification of domestic drugs: category 1.1 of original chemicals applicant: Chongqing re creation approval conclusion: approval of clinical trial of this product preparation III research of this new drug On October 13, 2015, Chongqing fuchuang submitted the clinical trial application to Chongqing food and Drug Administration for the first time and was accepted During the examination and approval process, the new drug has obtained the qualification of special review procedure and major special priority review The new drug is a class 1.1 chemical independently developed by the company and its holding subsidiary / unit (hereinafter referred to as "the group"), which mainly inhibits the activity of receptor tyrosine kinase on the surface of tumor cells, blocks the downstream signal pathway, and inhibits the growth and survival of tumor cells, so as to achieve the effect of tumor treatment The new drug showed strong in vitro and in vivo activity, good pharmacokinetic characteristics and safety in preclinical research As of the date of this announcement, no similar drugs with independent intellectual property rights with the same target of the new drug have been listed in China (excluding Hong Kong, Macao and Taiwan) According to imsmid ASTM (provided by imshealth, imshealth is the world's leading provider of professional information and strategic consulting services for the pharmaceutical and health industry), the global sales of similar drugs in 2015 was about $230 million As of the date of this announcement, the group has invested about 27 million yuan in research and development of the new drug at this stage IV risk indicates that although the clinical research of the new drug is expected to be good, according to the experience of new drug research and development at home and abroad, there are certain risks in new drug research and development, for example, phase I, phase II and / or phase III clinical trials may be terminated due to safety and / or effectiveness problems According to the regulatory requirements for new drug research and development in China, a series of clinical studies on the new drug should be carried out and approved by the national drug review department before it can be put on the market New drug research and development is a long-term work, there are many uncertain factors, please pay attention to the investment risk of investors It is hereby announced Board of directors of Shanghai Fosun Pharmaceutical (Group) Co., Ltd April 5, 2016